Trial Outcomes & Findings for Interleukin-15 (IL-5) in Combination With Avelumab (Bavencio) in Relapsed/Refractory Mature T-cell Malignancies (NCT NCT03905135)

Last Updated: 2022-09-13

Results Overview

The MTD is the dose level at which no more than 1 of up to 6 participants experience a dose-limiting toxicity (DLT) during the DLT evaluation window(s), or the dose below that at which at least 2 (of ≤6) participants have DLT. A dose-limiting toxicity (DLT) is defined as: any grade 3, 4, or 5 toxicity, if not incontrovertibly due to disease progression or an extraneous cause, and deemed possibly, probably or definitely related to interleukin-15 (IL-5) by the principal investigator (PI) or designee during the first 28 days of treatment. Grade 3 is severe. Grade 4 is life threatening. Grade 5 is death related to adverse event.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

8 participants

Primary outcome timeframe

First 28 days of treatment

Results posted on

2022-09-13

Participant Flow

No participants were enrolled on dose level 3, dose level 4, and expansion cohort because the manufacturer withdrew support due to low enrollment.

Participant milestones

Participant milestones
Measure	Dose Escalation - Dose Level 1, 1mcg/kg Interleukin-15 With 10 mg Avelumab Interleukin-15 (IL-15) will be administered by continuous intravenous infusion in a dose-escalation fashion with a starting dose level of 1 mcg/kg/day on days 1-5 of each of six cycles. Avelumab (intravenous (IV) over 1 hour) will be administered at a dose of 10 mg/kg on days 8 and 22 of each of six cycles.	Dose Level 2, 2mcg/kg Interleukin-15 With 10 mg Avelumab Interleukin-15 (IL-15) will be administered by continuous intravenous infusion in a dose-escalation fashion with a second dose level of 2 mcg/kg/day on days 1-5 of each of six cycles. Avelumab (intravenous (IV) over 1 hour) will be administered at a dose of 10 mg/kg on days 8 and 22 of each of six cycles.
Dose Escalation STARTED	6	2
Dose Escalation COMPLETED	1	0
Dose Escalation NOT COMPLETED	5	2
Dose Expansion STARTED	0	0
Dose Expansion COMPLETED	0	0
Dose Expansion NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Dose Escalation - Dose Level 1, 1mcg/kg Interleukin-15 With 10 mg Avelumab Interleukin-15 (IL-15) will be administered by continuous intravenous infusion in a dose-escalation fashion with a starting dose level of 1 mcg/kg/day on days 1-5 of each of six cycles. Avelumab (intravenous (IV) over 1 hour) will be administered at a dose of 10 mg/kg on days 8 and 22 of each of six cycles.	Dose Level 2, 2mcg/kg Interleukin-15 With 10 mg Avelumab Interleukin-15 (IL-15) will be administered by continuous intravenous infusion in a dose-escalation fashion with a second dose level of 2 mcg/kg/day on days 1-5 of each of six cycles. Avelumab (intravenous (IV) over 1 hour) will be administered at a dose of 10 mg/kg on days 8 and 22 of each of six cycles.
Dose Escalation Adverse Event	1	1
Dose Escalation Progressive disease	3	1
Dose Escalation Intercurrent illness	1	0

Baseline Characteristics

Interleukin-15 (IL-5) in Combination With Avelumab (Bavencio) in Relapsed/Refractory Mature T-cell Malignancies

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dose Escalation - Dose Level 1, 1mcg/kg Interleukin-15 With 10 mg Avelumab n=6 Participants Interleukin-15 (IL-15) will be administered by continuous intravenous infusion in a dose-escalation fashion with a starting dose level of 1 mcg/kg/day on days 1-5 of each of six cycles. Avelumab (intravenous (IV) over 1 hour) will be administered at a dose of 10 mg/kg on days 8 and 22 of each of six cycles.	Dose Level 2, 2mcg/kg Interleukin-15 With 10 mg Avelumab n=2 Participants Interleukin-15 (IL-15) will be administered by continuous intravenous infusion in a dose-escalation fashion with a second dose level of 2 mcg/kg/day on days 1-5 of each of six cycles. Avelumab (intravenous (IV) over 1 hour) will be administered at a dose of 10 mg/kg on days 8 and 22 of each of six cycles.	Total n=8 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Age, Continuous	59.8 years STANDARD_DEVIATION 5.26 • n=5 Participants	57.9 years STANDARD_DEVIATION 12.45 • n=7 Participants	59.33 years STANDARD_DEVIATION 6.53 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants	2 Participants n=7 Participants	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants	2 participants n=7 Participants	8 participants n=5 Participants

PRIMARY outcome

Timeframe: First 28 days of treatment

Outcome measures

Outcome measures
Measure	Dose Escalation - Dose Level 1, 1mcg/kg Interleukin-15 With 10 mg Avelumab n=6 Participants Interleukin-15 (IL-15) will be administered by continuous intravenous infusion in a dose-escalation fashion with a starting dose level of 1 mcg/kg/day on days 1-5 of each of six cycles.	Dose Level 2, 2mcg/kg Interleukin-15 With 10 mg Avelumab n=2 Participants Interleukin-15 (IL-15) will be administered by continuous intravenous infusion in a dose-escalation fashion with a second dose level of 2 mcg/kg/day on days 1-5 of each of six cycles.
Maximum Tolerated Dose (MTD) of Interleukin 15	NA mcg/kg The MTD was not found because the study was halted due to manufacturer withdrawal of support for low enrollment.	NA mcg/kg The MTD was not found because the study was halted due to manufacturer withdrawal of support for low enrollment.

SECONDARY outcome

Timeframe: From study opening through May 2022 when the study was completed with a maximum follow up of approximately 2 years and 11 months for any participant.

PFS is defined as the duration of time from the date of study enrollment until time of disease relapse, disease progression, or death, whichever occurs first. Disease relapse is Disease progression is \>20% increase in the sum of longest diameters of target lesions or appearance of a new lesion assessed by the Response Evaluation Criteria in Lymphoma (RECIL) 2017 criteria.

Outcome measures

Outcome measures
Measure	Dose Escalation - Dose Level 1, 1mcg/kg Interleukin-15 With 10 mg Avelumab n=6 Participants Interleukin-15 (IL-15) will be administered by continuous intravenous infusion in a dose-escalation fashion with a starting dose level of 1 mcg/kg/day on days 1-5 of each of six cycles.	Dose Level 2, 2mcg/kg Interleukin-15 With 10 mg Avelumab n=2 Participants Interleukin-15 (IL-15) will be administered by continuous intravenous infusion in a dose-escalation fashion with a second dose level of 2 mcg/kg/day on days 1-5 of each of six cycles.
Mean Progression Free Survival (PFS)	303 Days Standard Deviation 242	61.5 Days Standard Deviation 55.9

SECONDARY outcome

Timeframe: From study opening through May 2022 when the study was completed with a maximum follow up of approximately 2 years and 11 months for any participant.

EFS is defined as the duration of time from the date of study enrollment until time of disease relapse, disease progression, alternative therapy for lymphoma given (such as radiation), or death, whichever occurs first, and was estimated using Kaplan-Meier curves along with a 95% confidence interval. Disease relapse is Disease progression is \>20% increase in the sum of longest diameters of target lesions or appearance of a new lesion assessed by the Response Evaluation Criteria in Lymphoma (RECIL) 2017 criteria.

Outcome measures

Outcome measures
Measure	Dose Escalation - Dose Level 1, 1mcg/kg Interleukin-15 With 10 mg Avelumab n=6 Participants Interleukin-15 (IL-15) will be administered by continuous intravenous infusion in a dose-escalation fashion with a starting dose level of 1 mcg/kg/day on days 1-5 of each of six cycles.	Dose Level 2, 2mcg/kg Interleukin-15 With 10 mg Avelumab n=2 Participants Interleukin-15 (IL-15) will be administered by continuous intravenous infusion in a dose-escalation fashion with a second dose level of 2 mcg/kg/day on days 1-5 of each of six cycles.
Mean Event-free Survival (EFS)	176 Days Standard Deviation 140	33.54 Days Standard Deviation 0.98

SECONDARY outcome

Timeframe: From study opening through May 2022 when the study was completed with a maximum follow up of approximately 2 years and 11 months for any participant.

OS is defined as the time from the date of study enrollment until time of death from any cause and was estimated using Kaplan-Meier curves along with a 95% confidence interval.

Outcome measures

Outcome measures
Measure	Dose Escalation - Dose Level 1, 1mcg/kg Interleukin-15 With 10 mg Avelumab n=6 Participants Interleukin-15 (IL-15) will be administered by continuous intravenous infusion in a dose-escalation fashion with a starting dose level of 1 mcg/kg/day on days 1-5 of each of six cycles.	Dose Level 2, 2mcg/kg Interleukin-15 With 10 mg Avelumab n=2 Participants Interleukin-15 (IL-15) will be administered by continuous intravenous infusion in a dose-escalation fashion with a second dose level of 2 mcg/kg/day on days 1-5 of each of six cycles.
Mean Overall Survival (OS)	529 Days Standard Deviation 345	300 Days Standard Deviation 430

SECONDARY outcome

Timeframe: From the time the subject began protocol treatment until end of treatment, progression or start of another therapy or approximately 2 years

Response was assessed by the Response Evaluation Criteria in Lymphoma (RECIL) 2017 criteria and reported along with a 95% confidence interval. Complete response is complete disappearance of all target lesions. Partial response is ≥30% decrease in the sum of longest diameters of target lesions but not a complete response. Minor response is ≥10% decrease in the sum of longest diameters of target lesions but not a partial response. Stable disease is \<10% decrease or ≤20% increase in the sum of longest diameters of target lesions. Disease progression is \>20% increase in the sum of longest diameters of target lesions or appearance of a new lesion.

Outcome measures

Outcome measures
Measure	Dose Escalation - Dose Level 1, 1mcg/kg Interleukin-15 With 10 mg Avelumab n=6 Participants Interleukin-15 (IL-15) will be administered by continuous intravenous infusion in a dose-escalation fashion with a starting dose level of 1 mcg/kg/day on days 1-5 of each of six cycles.	Dose Level 2, 2mcg/kg Interleukin-15 With 10 mg Avelumab n=2 Participants Interleukin-15 (IL-15) will be administered by continuous intravenous infusion in a dose-escalation fashion with a second dose level of 2 mcg/kg/day on days 1-5 of each of six cycles.
Overall Response in Participants With Greater Than or Equal to 50% Programmed Death-ligand 1 (PD-L1) Expressing Tumor Cells Partial Response	2 Participants	0 Participants
Overall Response in Participants With Greater Than or Equal to 50% Programmed Death-ligand 1 (PD-L1) Expressing Tumor Cells Progressive Disease	2 Participants	2 Participants
Overall Response in Participants With Greater Than or Equal to 50% Programmed Death-ligand 1 (PD-L1) Expressing Tumor Cells Stable Disease	2 Participants	0 Participants
Overall Response in Participants With Greater Than or Equal to 50% Programmed Death-ligand 1 (PD-L1) Expressing Tumor Cells Minor Response	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 6 cycles (each cycle is 28 days) - approximately 168 days

OR is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Complete response is complete disappearance of all target lesions. Partial response is ≥30% decrease in the sum of longest diameters of target lesions but not a complete response. Minor response is ≥10% decrease in the sum of longest diameters of target lesions but not a partial response. Stable disease is \<10% decrease or ≤20% increase in the sum of longest diameters of target lesions. Disease progression is \>20% increase in the sum of longest diameters of target lesions or appearance of a new lesion assessed by the Response Evaluation Criteria in Lymphoma (RECIL) 2017 criteria.

Outcome measures

Outcome measures
Measure	Dose Escalation - Dose Level 1, 1mcg/kg Interleukin-15 With 10 mg Avelumab n=6 Participants Interleukin-15 (IL-15) will be administered by continuous intravenous infusion in a dose-escalation fashion with a starting dose level of 1 mcg/kg/day on days 1-5 of each of six cycles.	Dose Level 2, 2mcg/kg Interleukin-15 With 10 mg Avelumab n=2 Participants Interleukin-15 (IL-15) will be administered by continuous intravenous infusion in a dose-escalation fashion with a second dose level of 2 mcg/kg/day on days 1-5 of each of six cycles.
Number of Participants With Overall Best Response Complete Response	0 Participants	0 Participants
Number of Participants With Overall Best Response Partial Response	2 Participants	0 Participants
Number of Participants With Overall Best Response Minor Response	0 Participants	0 Participants
Number of Participants With Overall Best Response Stable Disease	2 Participants	0 Participants
Number of Participants With Overall Best Response Progressive Disease	2 Participants	2 Participants

SECONDARY outcome

Timeframe: From the time that response to therapy is first documented until progressive disease is observed or the subject is lost to follow-up or approximately 2 years.

DOR is measured from the time measurement criteria are met for complete response (CR) or partial response (PR) (whichever is recorded first) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started), death, or, in the absence of progressive disease (PD), date of last assessment. The response rate was assessed by the Response Evaluation Criteria in Lymphoma (RECIL) 2017 criteria and reported along with a 95% confidence interval. Complete response is complete disappearance of all target lesions. Partial response is ≥30% decrease in the sum of longest diameters of target lesions but not a complete response. Disease progression is \>20% increase in the sum of longest diameters of target lesions or appearance of a new lesion.

Outcome measures

Outcome measures
Measure	Dose Escalation - Dose Level 1, 1mcg/kg Interleukin-15 With 10 mg Avelumab n=6 Participants Interleukin-15 (IL-15) will be administered by continuous intravenous infusion in a dose-escalation fashion with a starting dose level of 1 mcg/kg/day on days 1-5 of each of six cycles.	Dose Level 2, 2mcg/kg Interleukin-15 With 10 mg Avelumab n=2 Participants Interleukin-15 (IL-15) will be administered by continuous intravenous infusion in a dose-escalation fashion with a second dose level of 2 mcg/kg/day on days 1-5 of each of six cycles.
Mean Duration of Response (DOR)	107 Days Standard Deviation 115	NA Days Standard Deviation NA Cannot report because none in dose level 2 had a partial response or complete response.

OTHER_PRE_SPECIFIED outcome

Timeframe: First 28 days of treatment

A dose-limiting toxicity (DLT) is defined as: any grade 3, 4, or 5 toxicity if not incontrovertibly due to disease progression or an extraneous cause, and deemed possibly, probably or definitely related to interleukin-15 (IL-5) or avelumab by the principal investigator (PI) or designee during the first 28 days of treatment. Grade 3 is severe. Grade 4 is life threatening. Grade 5 is death related to adverse event.

Outcome measures

Outcome measures
Measure	Dose Escalation - Dose Level 1, 1mcg/kg Interleukin-15 With 10 mg Avelumab n=6 Participants Interleukin-15 (IL-15) will be administered by continuous intravenous infusion in a dose-escalation fashion with a starting dose level of 1 mcg/kg/day on days 1-5 of each of six cycles.	Dose Level 2, 2mcg/kg Interleukin-15 With 10 mg Avelumab n=2 Participants Interleukin-15 (IL-15) will be administered by continuous intravenous infusion in a dose-escalation fashion with a second dose level of 2 mcg/kg/day on days 1-5 of each of six cycles.
Number of Participants With a Dose-limiting Toxicity (DLT)	1 Participants	1 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Date treatment consent signed to date off study, approximately 21 months and 18 days for the dose level 1 and 3 months and 19 days for the dose level 2.

Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

Outcome measures

Outcome measures
Measure	Dose Escalation - Dose Level 1, 1mcg/kg Interleukin-15 With 10 mg Avelumab n=6 Participants Interleukin-15 (IL-15) will be administered by continuous intravenous infusion in a dose-escalation fashion with a starting dose level of 1 mcg/kg/day on days 1-5 of each of six cycles.	Dose Level 2, 2mcg/kg Interleukin-15 With 10 mg Avelumab n=2 Participants Interleukin-15 (IL-15) will be administered by continuous intravenous infusion in a dose-escalation fashion with a second dose level of 2 mcg/kg/day on days 1-5 of each of six cycles.
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)	6 Participants	2 Participants

Adverse Events

Dose Escalation - Dose Level 1, 1mcg/kg Interleukin-15 With 10 mg Avelumab

Serious events: 6 serious events

Other events: 3 other events

Deaths: 3 deaths

Dose Level 2, 2mcg/kg Interleukin-15 With 10 mg Avelumab

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Dose Escalation - Dose Level 1, 1mcg/kg Interleukin-15 With 10 mg Avelumab n=6 participants at risk Interleukin-15 (IL-15) will be administered by continuous intravenous infusion in a dose-escalation fashion with a starting dose level of 1 mcg/kg/day, a second dose level of 2 mcg/kg/day, a third dose level at 3 mcg/kg/day, and a fourth dose level at 4 mcg/kg/day on days 1-5 of each of six cycles. Avelumab (intravenous (IV) over 1 hour) will be administered at a dose of 10 mg/kg on days 8 and 22 of each of six cycles.	Dose Level 2, 2mcg/kg Interleukin-15 With 10 mg Avelumab n=2 participants at risk Interleukin-15 (IL-15) will be administered by continuous intravenous infusion in a dose-escalation fashion with a starting dose level of 1 mcg/kg/day, a second dose level of 2 mcg/kg/day, a third dose level at 3 mcg/kg/day, and a fourth dose level at 4 mcg/kg/day on days 1-5 of each of six cycles. Avelumab (intravenous (IV) over 1 hour) will be administered at a dose of 10 mg/kg on days 8 and 22 of each of six cycles.
Infections and infestations Bacteremia	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 21 months and 18 days for the dose level 1 and 3 months and 19 days for the dose level 2. Three participants died from disease progression during the long-term survival follow-up phase of the study (they were only being called once every 3 months to check to see if they died and to learn of new cancer treatments). We were no longer tracking adverse events (AEs) at the time of death, thus only one death from progressive disease is listed in the serious adverse events table below.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 21 months and 18 days for the dose level 1 and 3 months and 19 days for the dose level 2. Three participants died from disease progression during the long-term survival follow-up phase of the study (they were only being called once every 3 months to check to see if they died and to learn of new cancer treatments). We were no longer tracking adverse events (AEs) at the time of death, thus only one death from progressive disease is listed in the serious adverse events table below.
Metabolism and nutrition disorders Dehydration	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 21 months and 18 days for the dose level 1 and 3 months and 19 days for the dose level 2. Three participants died from disease progression during the long-term survival follow-up phase of the study (they were only being called once every 3 months to check to see if they died and to learn of new cancer treatments). We were no longer tracking adverse events (AEs) at the time of death, thus only one death from progressive disease is listed in the serious adverse events table below.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 21 months and 18 days for the dose level 1 and 3 months and 19 days for the dose level 2. Three participants died from disease progression during the long-term survival follow-up phase of the study (they were only being called once every 3 months to check to see if they died and to learn of new cancer treatments). We were no longer tracking adverse events (AEs) at the time of death, thus only one death from progressive disease is listed in the serious adverse events table below.
General disorders Disease progression	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 21 months and 18 days for the dose level 1 and 3 months and 19 days for the dose level 2. Three participants died from disease progression during the long-term survival follow-up phase of the study (they were only being called once every 3 months to check to see if they died and to learn of new cancer treatments). We were no longer tracking adverse events (AEs) at the time of death, thus only one death from progressive disease is listed in the serious adverse events table below.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 21 months and 18 days for the dose level 1 and 3 months and 19 days for the dose level 2. Three participants died from disease progression during the long-term survival follow-up phase of the study (they were only being called once every 3 months to check to see if they died and to learn of new cancer treatments). We were no longer tracking adverse events (AEs) at the time of death, thus only one death from progressive disease is listed in the serious adverse events table below.
Gastrointestinal disorders Enterocolitis	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 21 months and 18 days for the dose level 1 and 3 months and 19 days for the dose level 2. Three participants died from disease progression during the long-term survival follow-up phase of the study (they were only being called once every 3 months to check to see if they died and to learn of new cancer treatments). We were no longer tracking adverse events (AEs) at the time of death, thus only one death from progressive disease is listed in the serious adverse events table below.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 21 months and 18 days for the dose level 1 and 3 months and 19 days for the dose level 2. Three participants died from disease progression during the long-term survival follow-up phase of the study (they were only being called once every 3 months to check to see if they died and to learn of new cancer treatments). We were no longer tracking adverse events (AEs) at the time of death, thus only one death from progressive disease is listed in the serious adverse events table below.
Blood and lymphatic system disorders Febrile neutropenia	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 21 months and 18 days for the dose level 1 and 3 months and 19 days for the dose level 2. Three participants died from disease progression during the long-term survival follow-up phase of the study (they were only being called once every 3 months to check to see if they died and to learn of new cancer treatments). We were no longer tracking adverse events (AEs) at the time of death, thus only one death from progressive disease is listed in the serious adverse events table below.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 21 months and 18 days for the dose level 1 and 3 months and 19 days for the dose level 2. Three participants died from disease progression during the long-term survival follow-up phase of the study (they were only being called once every 3 months to check to see if they died and to learn of new cancer treatments). We were no longer tracking adverse events (AEs) at the time of death, thus only one death from progressive disease is listed in the serious adverse events table below.
Vascular disorders Hypotension	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 21 months and 18 days for the dose level 1 and 3 months and 19 days for the dose level 2. Three participants died from disease progression during the long-term survival follow-up phase of the study (they were only being called once every 3 months to check to see if they died and to learn of new cancer treatments). We were no longer tracking adverse events (AEs) at the time of death, thus only one death from progressive disease is listed in the serious adverse events table below.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 21 months and 18 days for the dose level 1 and 3 months and 19 days for the dose level 2. Three participants died from disease progression during the long-term survival follow-up phase of the study (they were only being called once every 3 months to check to see if they died and to learn of new cancer treatments). We were no longer tracking adverse events (AEs) at the time of death, thus only one death from progressive disease is listed in the serious adverse events table below.
Investigations Platelet count decreased	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 21 months and 18 days for the dose level 1 and 3 months and 19 days for the dose level 2. Three participants died from disease progression during the long-term survival follow-up phase of the study (they were only being called once every 3 months to check to see if they died and to learn of new cancer treatments). We were no longer tracking adverse events (AEs) at the time of death, thus only one death from progressive disease is listed in the serious adverse events table below.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 21 months and 18 days for the dose level 1 and 3 months and 19 days for the dose level 2. Three participants died from disease progression during the long-term survival follow-up phase of the study (they were only being called once every 3 months to check to see if they died and to learn of new cancer treatments). We were no longer tracking adverse events (AEs) at the time of death, thus only one death from progressive disease is listed in the serious adverse events table below.

Other adverse events

Additional Information

Dr. Kevin C. Conlon

National Cancer Institute

Phone: 240-858-3570

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place